Genetics

The
human genetic code has received a great deal of attention since
gene technology as a science emerged from Watson's and Crick's discovery
of the structure of the DNA molecule (for which they received the
1962 Nobel Prize). Today, researchers have in principle mapped the
entire set of human genes. Many expect that an increasing number
of applications of this new knowledge will bring a revolution within,
for example, medicine and plant development. With gene
technology's rapid growth - and increasingly bold predictions
concerning what can be accomplished with its help in the near future
- a number of ethical issues have also appeared, concerning things
such as ownership or patentability of genes and what gene technology
means for people's private lives and integrity.

What is gene technology?

Gene technology is primarily a technology for mapping genes - humans' genetic makeup. Genes consist of a certain sequence of nucleotides (A, G, T, or C). Using this knowledge, we can further analyze hereditary diseases, change an organism's genetic makeup so that its characteristics are changed, and perform gene therapy (correcting or exchanging pathogenic genes in an individual). Another application of this knowledge is the possibility to match medicines directly to an individual's genome, his/her specific set of genes. For example, if 5% of a population does not react to a medicine it may be possible to find a gene common to this group that explains this, which can lead to the development of an effective treatment. In short, gene technology in the broadest sense entails using knowledge about the human genetic makeup and its functions to solve problems or manufacture products. In this wider conception, biotechnology concerns using qualities of cells or their parts in a technical context (SOU 2000:103). Biotechnology have a long succession of applications, e.g. computer technology, chemistry, materials development and the judicial system. This is a development of which we have yet only seen the beginning.

Swedish regulation

The fundamental regulations concerning genetically modified organisms
can be found in Chapters 13 and 14 of the he Swedish Environmental
Code, which replaced the previous gene technology law. Ordinance
2000:271
on the contained use of genetically modified organisms provides
detailed regulations regarding application. These regulations rest
on the EU directive 2001/18/EC
on the deliberate release into the environment of genetically modified
organisms and 2009/41/EEC
on the contained use of genetically modified micro-organisms. In
Sweden, Arbetarskyddsstyrelsen (the National Board of Occupational
Safety and Health - now Arbetsmiljöverket, the Swedish
Work Environment Authority) has also published corresponding regulations
(AFS 2011:02). Kemikalieinspektionen (the Swedish Chemicals
Inspectorate) has issued regulations on chemical products and biotechnical organisms. Additionally, there
are The Swedish Agency for Marine and Water Management's regulations on genetically modified aquatic organisms (FIFS 2004:2).

In Sweden, the government authority the
Gene Technology Advisory Board has the tasks of following national
and international development in the area of gene technology, monitoring
ethical questions and, via its advisory position, promoting an ethically
defensible and secure use of gene technology so that people's and
animals' health and environment are protected. The board notifies
the government if a field of application or planned use of gene
technology is questionable from an ethical or humanitarian viewpoint.

Experiments on humans are regulated foremost by the The Genetic Integrity Act (SFS 2006:351),
the main idea of which is that experiments on fertilized eggs are
allowed during the first 14 days after fertilization. The eggs must
then be destroyed. Most countries, including Sweden, (through laws
or moratoria)
do not allow research involving gamete therapy (by which the cells’
altered character would be inherited by future generations).

European standards

There has surfaced strong apprehension that the new gene technology
can, for example, trespass on people's right to integrity and a
private life, or be discriminatory. Not least worrisome are what
have been seen as threats regarding genetically improved humans
and cloning. Such issues have brought about a number of documents.
The year 1997 saw the publication of the Council
of Europe's Convention for the protection of Human Rights and
dignity of the human being with regard to the application of biology
and medicine, which was supplemented with a protocol concerning
the Prohibition
of Cloning Human Beings. In 2004, the Article 29 Working Party has developed a Working
document on Genetic Data. The Council of Europe's Parliamentary Assembly published Order
No. 534 (1997) on research and the cloning of human beings and in Recommendation
1468 (2000) they call for more care and suggest that the EU renegotiate
many of its fundamental texts. Recommendation
1512 (2001) again addresses the protection of the human genome,
while Resolution
1352 discusses research on human stem cells.

The European Commission has developed 25
recommendations on the ethical, legal, and social implications of
genetic testing (2004) and a declaration in 2013. The European Parliament created a resolution
against
human cloning 15 January 1998. Due to Great Britain's proposal to allow
'therapeutical cloning' (cloning with a medical aim other than reproduction),
the Parliament again presented a strongly critical resolution
on human cloning. In practice, the European Union has
adopted a rather restrictive position. European scientists have
had a voluntary moratorium on human reproductive cloning since 1999,
through their organisation The European Society of Human Reproduction
and Embryology (ESHRE).

International

For its part, the United Nations presented a declaration
on the human genome and human rights, which was further developed
into UNESCO's Declaration
on the Human Genome and Human Rights of 11 November 1997.

The Council for International Organizations of Medical Sciences
(CIOMS) has authored The
Declaration of Inuyama on Human Genome Mapping, Genetic Screening
and Gene Therapy. The World Medical Association (WMA) published
a Statement
on In-Vitro Fertilization and Embryo Transplantation. They have
also taken a stand on Genetics and Medicine. The Human Genome Organisation
(HUGO) has its own ethics committee that, in addition to
a Statement
on Cloning, has written a Statement
on the Principled Conduct of Genetics Research. They have also
issued a Statement
on Benefit-Sharing and a Statement
on Human Genomic Databases.

Lately new techniques like CRISPR have caused concerns, as they enable gene editing with great precision. In an international meeting the following view was adopted: On Human Gene Editing: International Summit Statement. Then the report Human Genome Editing: Science, Ethics, and Governance was issued by The National Academies, US.

The international Biotechnology Industry Organization (BIO)
has formulated policy
documents and recommendations on issues such as genetic discrimination,
integrity, cloning and genetic testing. The corresponding European
organisation, Europabio, also has core
ethical values as well as a collection of various position
papers. The European Society of Human Genetics has a
number of policy
documents on genetics. International Society of Nurses in
Genetics has published various position
statements. An initiative is The Budapest Meeting 2005: Intensified
Networking on Ethics of Science - The Case of Reproductive Cloning,
Germline Gene Therapy and Human Dignity. Finally, we can mention that
the Indigenous Peoples Council on Biocolonialism has contributed
the Ukupseni
Declaration (as well as a number of similar initiatives; see
here
for a list), which expresses strong criticism of attempts to map
differences between different populations' genomes. Regarding this
isse, see also the article The
ethics of characterizing difference: guiding principles on using
racial categories in human genetics.

For specific questions about, for example, biobanks or stem cell
research, see the pages elsewhere in CODEX on those topics. Another debated question concerns
xenotransplantation. Research involving such work is allowed in Sweden. WHO has issued recommendations
concerning xenotransplantation. The Council of Europe's Committee
of Ministers has issued its Recommendation
No. (2003) 10 on xenotransplantation.